Wound shield

ABSTRACT

A preformed wound shield includes a frame formed of one or more layers of suitable material and any suitable covering. Exudate absorbing or transporting material may also be one of two or more layers of material forming the frame.

RELATED APPLICATIONS

This application claims priority to copending U.S. Provisional PatentApplication 60/773,252 filed Feb. 13, 2006.

FIELD OF THE INVENTIONS

The inventions described below relate to the field of wound caremanagement.

BACKGROUND OF THE INVENTIONS

Wounds occur when the integrity of any tissue is compromised, affectingone or more layers of skin or underlying tissue. Wounds may be caused byan act, surgical procedure, an infectious disease or an underlyingcondition. Examples of open wounds include punctures, abrasions, cuts,lacerations and burns. Chronic wounds are also common ailments andinclude pressure ulcers, diabetic ulcers, arterial ulcers, venous ulcersor combination of all the above. Despite much progress made in the woundcare industry, an efficient and effective method and apparatus forprotecting the wound from injurious contacts is not readily available.

Injurious contacts with foreign objects may be caused from varioussources, ranging from brushing of clothing or bed sheets to fresh,uncovered wounds to adherence of wound dressing to the wound. The latterissue, referred to here as the sticking issue, leads to deleteriousconsequences for the patient. This problem is particularly exacerbatedwhen wounds are left unattended for a substantial period. It is reportedthat in certain circumstances patients are administered morphine towithstand the pain caused from dressing removal, especially with woundshaving a large surface area. Equally important, tearing of skin graft,newly formed cells or scab adhered to dressing disrupts the healingprocess.

Wounds are generally covered to prevent contamination and resultinginfection. Wounds may also be covered for other reasons, includingretaining moisture and absorption of exudate. Wound covering hastraditionally consisted of application of dressings that are in directcontact with the wound. When directly applied on the wound, dressingsadhere and mechanically anchor to wound surface, which may includediffused wound fluid, skin graft, new epidermal cells forming over thewound or the scabby covering of the wound.

The sticking issue has traditionally been addressed by soaking the woundand the dressing adhering to it in water for some time to soften thescab and make removal easier. Another method is the application ofantibiotic ointments, such as polymyxin B sulfate or bacitracin, to keepthe bandage from sticking to the wound. These methods, however, have notsufficiently addressed the sticking issue. As can be appreciated byhealth care professionals, soaking in water or application of ointmentsare not always practicable or recommended.

To better address the sticking issue the medical industry has developed“non-stick” dressings such as Telfa® and Xeroform® and other dressingssuch as hydrocolloids, alginates, hydrofilms, etc. Non-stick, however,is a relative term. Non-stick dressings merely stick less than theirtraditional counterparts, e.g., cotton gauze. Another problem with thesedressings is that their cost is prohibitive for use on wounds requiringconstant change of dressing.

Similar to the traditional and “non-stick” dressings described above,conventional “non-contact” dressings also fail to efficiently andeffectively protect the wound from contact, including addressing thesticking issue. Conventional non-contact dressings are also generallybulky, complicated to apply having too many subparts, unable to manageexudate, unable to manage moisture, generally inflexible and expensive.

What is needed is a method and apparatus for dressing wounds or othersuitable injuries that is flexible to prevent contact with the surfaceof the wound, permit management of exudate from the wound and improvethe environment immediately adjacent the wound.

SUMMARY

A wound shield includes a frame formed of one or more layers of suitablematerial and any suitable covering. Exudate absorbing material may alsobe one of two or more layers of material forming the frame. The layersmay be arranged to keep the exudate absorbing layer at some selecteddistance from a patient's skin. Any suitable dressing may be securedover the frame providing separation between the wound and the dressing.The wound frame may provide pressure relief around a wound or pressuresore to permit healing. A frame may be composed of one or more layers ofany suitable material and may include adhesive on one or more surfacesto secure the frame to the wound site and or to secure the dressing tothe frame. One layer of the two or more layers of material forming theframe may be a wicking or conduit material that draws exudate from thewound and transports the exudate to any suitable media for exudatestorage. The exudate storage may be one or more layers of a dressingcovering the wound site, or it may be a removable reservoir.

A wound shield for exudate management may include a frame tocircumscribe a wound. Any suitable dressing may be secured over theframe providing separation between the wound and the dressing. The woundframe may provide pressure relief around a wound or pressure sore topermit healing. A frame may be composed of one or more layers of anysuitable material and may include adhesive on one or more surfaces tosecure the frame to the wound site and or to secure the dressing to theframe.

Exudate as used in this application may also include any solid or liquidproduced by the patient's body, or applied to or into a patients bodythat sloughs, falls, flows, or is discharged from a wound, the woundsite or the tissue surrounding the wound.

In another aspect of the present disclosure, a frame may be formed ofmaterial for absorbing wound exudate. Exudate absorbing material mayalso be one of two or more layers of material forming the frame. Thelayers may be arranged to keep the exudate absorbing layer at someselected distance from a patients skin.

A wound shield for dynamic exudate management may include two or morelayers of material. One layer of the two or more layers of material maybe a wicking or conduit material that draws exudate from the wound andtransports the exudate to any suitable media for exudate storage. Theexudate storage may be one or more layers of a dressing covering thewound site, or it may be a removable reservoir.

A wound shield for exudate management may also include an exteriormembrane to permit exudate transfer out of the wound space. A woundshield including an exterior membrane may also include an exudatecollection apparatus surrounding the wound shield for collecting andremoving exudate from the wound shield and from the patient.

A wound shield for exudate management may also include one or morereclosable or self-closing apertures in the frame to enable exudatemanagement. The exudate aperture may be engaged as often as necessaryfor suitable wound care.

A wound shield may include a frame to circumscribe a wound. Any suitabledressing may be secured over the frame, the frame providing separationbetween the wound and the dressing. The wound frame may provide pressurerelief around a wound or pressure sore to permit healing, allowcompression for venous ulcers, retain moisture within the woundenvironment, absorb exudate, relieve pain and trauma associated withdressing removal, allow debridement and application of topicalmedications and or other compounds or chemicals, accelerate healing andfacilitate monitoring of wounds. A frame may be composed of one or morelayers of any suitable material and may include adhesive on one or moresurfaces to secure the frame to the wound site and or to secure thedressing to the frame. A wound shield may be used for humans or anysuitable animal.

A wound shield according to the present disclosure may be a simple,versatile, inexpensive and readily applicable apparatus and method forwound protection. It may include a wound-protecting frame that may adaptto the contour of the wound site and may be used with any suitabledressing. A wound shield prevents foreign objects such as clothing,dressings and other such items from contacting the wound. Cotton gauzeor other suitable dressing may be placed on or engage a wound protectingframe to completely protect the wound from harmful contact with anyobject. Alternatively, special covers, seals, and or lids may be placedon the wound shield to control moisture, simplify wound monitoring anddebridement and application of medications.

A wound shield according to the present disclosure may adhere to skinsurrounding a wound via adhesive applied to a surface of thewound-protecting frame to engage the skin. Medical grade, hypoallergenicadhesives are preferred, although any suitable adhesive may be used suchas rubber-based, acrylic, vinyl ether and suitable pressure-sensitiveadhesives. For their obvious advantages, adhesives that adhere to bodyhair less than their conventional counterparts are preferred. Adhesivesmay also be added to one or more surfaces of a wound-protecting framenot in contact with skin to engage any suitable dressing, cover, lid orany other suitable closure. Alternatively, no adhesive is required tosecure the wound shield to a patient, and the wound shield may beretained in place by the pressure applied from the dressing wrappedaround the wound.

In use, a frame is placed around a wound, creating a boundary andproviding a plane separate from the plane of the wound to support thedressing. A wound shield according to the present disclosure may adaptto the contours of a wound site located on any surface of a body. Inaddition, the frame may be made of inexpensive material.

Any suitable dressing may be used in conjunction with the frame, and mayrange from inexpensive, commonly used cotton gauze to more costly andsophisticated dressings, including for example, those constructed fromtransparent and or multi-layered material with qualities such as exudateabsorption, bacteria impermeability and controlled air and or moisturepermeability. Health care professionals may mix and match variousdressings without restriction to complex and/or costly non-contactdressings.

A wound shield according to the present disclosure has sufficientrigidity to prevent injurious contacts to the wound, including thosecaused by dressing adhering to the wound surface. The frame preventscontact to wounds regardless of their size or location with any suitabledressing.

A wound shield according to the present disclosure may be used for swiftand effective wound debridement using any suitable technique. Forexample, a wound shield may be used to create a controlled spaceadjacent a wound for biological debridement, use of maggots or othersuitable techniques. Alternatively, mechanical and or chemicaldebridement may also be effected within the controlled space. Surgicaldebridement may also be performed without removing the frame from aroundthe wound. The wound shield minimizes wound and peri-wound disturbanceby avoiding repetitive dressing removals with the associated woundsurface disturbance.

A wound shield including a frame to circumscribe a wound may alsoinclude a circulating system for circulating any suitable fluid tomaintain a desired environment. Any suitable dressing may be securedover the frame providing separation between the wound and the dressing.The wound frame may provide pressure relief around a wound or pressuresore to permit healing. A frame may be composed of one or more layers ofany suitable material and may include adhesive on one or more surfacesto secure the frame to the wound site and or to secure the dressing tothe frame.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a frame according to the presentdisclosure.

FIG. 2 is a cross section of the frame of FIG. 1 taken along A-A.

FIG. 3 is an alternate cross section of the frame of FIG. 1.

FIG. 4 is another alternate cross section of the frame of FIG. 1.

FIG. 5 is a still alternate cross section of the frame of FIG. 1.

FIG. 6 is a top view of an alternate frame according to the presentdisclosure.

FIG. 7 is a top view of another alternate frame according to the presentdisclosure.

FIG. 8 is a top view of yet another alternate frame according to thepresent disclosure.

FIG. 9 is a perspective view of a frame surrounding a small wound on theforearm.

FIG. 10 is a cross section of the frame and dressing on the wound ofFIG. 9.

FIG. 11 is a perspective view of a frame surrounding a long, oddlyshaped laceration on the forearm.

FIG. 12 is a perspective view of a wound frame surrounding twoproximately located wounds on the forearm.

FIG. 13 is a perspective view of a support or bridge member according tothe present disclosure.

FIG. 14 is a side view of an alternate support or bridge memberaccording to the present disclosure.

FIG. 15 is a perspective view of a wound frame surrounding twoproximately located wounds on the forearm.

FIG. 16 is a perspective view of an alternate flexible wound frameaccording to the present disclosure.

FIG. 17 is a perspective view of an alternate flexible wound frameaccording to the present disclosure.

FIG. 18 is a cross section of the frame of FIG. 17 taken along C-C.

FIG. 19 is a cross section of the frame of FIG. 17 taken along C-C withan alternate scaffold.

FIG. 20 is an alternate cross section of the frame of FIG. 17.

FIG. 21 is another alternate cross section of the frame of FIG. 17.

FIG. 22 is yet another alternate cross-section of the frame of FIG. 17.

FIG. 23 is an alternate cross section of the frame of FIG. 17 with awicking element.

FIG. 24 is another alternate cross section of the frame of FIG. 23.

FIG. 25 is a perspective view of an alternate frame according to thepresent disclosure.

FIG. 26 is a cross section of an alternate frame and lid configuration.

FIG. 27 is a cross section of another alternate frame and lidconfiguration.

FIG. 28 is a cross section of a frame with a vacuum lid configuration.

FIG. 29 illustrates a device for isolating a wound and providing heat tothe wound to encourage healing.

FIG. 30 illustrates the device of FIG. 29 modified to provide fluid flowover the wound to encourage healing.

FIG. 31 is another still alternate cross section of the frame of FIG.17.

FIG. 32 is yet another still alternate cross-section of the frame ofFIG. 17.

FIG. 33 is a cross section of yet another alternate frame configurationwith an absorbent dressing.

FIG. 34 is a cross section of an alternate frame configuration includingexudate capture and storage.

FIG. 35 is a cross section of an alternate frame configuration includingexudate removal apertures and removal apparatus.

FIG. 36 is a cross section of an alternate frame configuration withcircumferential steps of varying heights.

FIG. 37 is a cross section of an alternate frame configuration having aradially varying thickness.

DETAILED DESCRIPTION OF THE INVENTIONS

Referring to FIG. 1 and FIG. 2, frame 10 provides perimeter protectionfor a wound and may adapt to the contours of the wound site. Frame 10includes exterior side 14 facing away from the wound and interior side16 facing the wound, superficial surface 12 for engaging dressings andcutaneous surface 18 in contact with the patient's skin, or any otherdressing or apparatus in contact with the patient's skin. Any suitableadhesive may be applied to cutaneous surface 18 and or superficialsurface 12 such as adhesive 28 and 22 respectively. Adhesive layers 22and 28 may also be covered by a strip or a film, such as film 24 and 26respectively, that can be peeled off at the time of use. Adhesive 28secures frame 10 to skin surrounding a wound, or in some applications,to a dressing or apparatus that is in contact with the patient's skin.When applied to superficial surface 12, adhesive layer 22 may engage adressing or other suitable cover to frame 10.

In use, frame 10 completely circumscribes a wound as shown in FIG. 9.Frame 10 may have any suitable span 31 and a suitable cross-section asshown in FIG. 2 including height 30 and width 32. The size of a woundsite to be circumscribed may require height 30 and width 32 to beavailable in different dimensions. Larger wounds may have a dressing sagand inadvertently contact the wound. Height 30 and span 31 and thecharacteristics of a dressing may be selected and considered to minimizeinadvertent dressing to wound contact.

Frame 10 may be constructed from any suitable material such as forexample, silicone; polymers such as polypropylene, polyethylene andpolyurethane may also be used to form a suitable wound protector.Depending on its specific use, additional features of a wound shield mayinclude impermeability or controlled permeability to water, bacteria andair, and absorption of fluids exuding from the wound bed. A wound shieldaccording to the present disclosure may also include a selectablemoisture vapor transmission rate (MVTR). Polyurethane foam may be usedto form a wound-protecting frame for its ability to absorb exudates.

Referring now to FIGS. 3-5, frame 10 may adopt any suitable crosssection.

Referring now to FIGS. 6, 7 and 8 alternatively, a frame such as frame34, 36 or 38 may have any suitable shape or geometry.

Referring now to FIG. 9 and FIG. 10, frame 46 may be applied to anysurface of a patient such as forearm 44 using adhesive 58. Frame 46circumscribes wound 48. When dressing 52 is used to promote healing ofwound 48, frame 46 prevents dressing 52 from contacting wound 48 bycreating a separation 56 between dressing 52 and wound plane or skinsurface 54. Separation 56 is controlled by height 30 of the frame.

As briefly described above, dressing 52 may be any suitable dressing.Dressing 52 may also include adhesive along its perimeter orlongitudinal and/or its transverse lengths, so to facilitate itsadherence to skin surrounding frame 46. Alternatively, dressing 52 maybe wrapped around the arm or other body parts on which wound 48 issituated, or dressing 52 may be sized or cut to size to engage onlyframe 46. Dressings such as dressing 52 may have any suitable MVTRparameters.

Referring now to FIG. 11, dressing 60 may be used to secure frame 66around wound 64, which is a long, narrow, oddly shaped laceration.Adhesive may be included around perimeter 62 of dressing 60. One or moredressing such as dressing 60 may be used. Dressing 60 may be appliedalong the length, width, or in tandem with another dressing 60 or otherdressings to protect wound 64.

Referring now to FIG. 12, frame 70 may be used to protect one or moreproximately located wounds such as wounds 72 and 74 on forearm 76.Dressing 78 may be separated from scored dressing sheet 75 which mayhave one or more dressings scored into sheet 75. Dressings such asdressing 52 or dressing 78 may be separated from sheet 75 along scoring52A or 78A respectively. Any size or number of dressings may bepre-scored into a dressing sheet such as sheet 75.

A frame according to the present disclosure may not always completelycircumscribe a wound. For wounds positioned in awkward body locations,such as the elbow and knee or for any other reason, a frame may be cutinto two or more suitable lengths or frame elements to be positionedaround the wound as discussed above. Such manipulation may allowpositioning of a dressing without contacting the wound.

In certain circumstances health care professionals may recommend theairing of the wound, i.e., not covering the wound with any dressing. Assuch, a frame according to the present disclosure may be used to simplyprotect the wound from physical contact with other foreign objects, suchas clothing or bed sheets. This configuration may also be suitable fortreatment of any pressure or abrasion sores some of which may be causedby long-term immobility. A frame may be used to surround such sores andrelieve the local pressure and permit the sores to heal.

For patients allergic to medically approved adhesives, the frame may beprovided without adhesive or, alternatively, with adhesive only onsurface 12. In such circumstances, frame 10 must be secured to the woundsite with sufficient and appropriate pressure to engage frame 10 withthe wound site.

For wound configurations such as illustrated in FIG. 11 and or FIG. 12,particularly large wounds, structurally weak dressings or high pressurewound or sore sites it may be necessary to provide additional supportwithin the perimeter of a frame to support the selected dressing orrelieve external pressure.

Referring now to FIG. 13, one or more bridge members such as bridgemember 80 may be used with the frame of the present disclosure toprovide additional wound protection. A bridge member may be used withwounds having large surface area or with dressings having littlestructural strength, or in situations where pressure may be applied tothe center of the wound area. Positioning of one or more bridge memberssuch as bridge 82 on frame 70, as depicted in FIG. 15, may preventdressing 78 from sinking and touching wounds 72 or 74.

A bridge member can have any suitable shape including straight or curvededges, ends or separations. A bridge may also be constructed frominexpensive medical grade rigid plastic polymers, metal or woodparticularly conditioned for medical use. Such material may bestructurally adapted to allow breakage or separation along segment linessuch as lines 86 and 88.

Medical grade adhesive may also be applied to second surface 90 whichwill come in contact with the frame. A thin layer of film or stripremovable at time of use may cover the adhesive as discussed above withrespect to the frame. Alternatively, bridge member 80 may have adhesiveon both second side 90 and first side 92 to adhere not only to theframe, but also to the dressing.

Referring now to FIG. 14, alternate bridge member 84 includes aplurality of slots 94. Each slot or opening such as slot 94 may have anysuitable shape and dimension providing that width 96 is sized to permitengagement of a suitable frame in the slot.

Referring to FIG. 16, a second frame 50 may be positioned on superficialsurface 42 of a first frame 40. This configuration may be used insituations where a greater protective height around a wound ispreferable. A stacked assembly may include more than two frames.

Referring now to FIG. 17 and FIG. 18, frame 140 may have many differentcross sectional dimensions as well as constituent configurations. Framesas discussed above may adopt any suitable geometry. For someapplications it may be useful for a frame to be composed of two or moreinternal layers such as layers 150 and 152 illustrated in FIG. 18. Forexample, layer 150 may be absorbent, or may include any suitableantibiotic such as for example silver metal and or its salts. Layer 152may be made from any suitable material.

In some situations it may be preferable to change one or more layersclosest to a wound when the layer or layers become saturated orotherwise unsuitable to remain close to the wound. Layer 150 may beremovable to permit changing one or more layers. A scaffold or othersuitable apparatus such as scaffold 138 may be secured to exterior layer152. Internal layer 150 may be secured or otherwise engaged to either orboth layer 152 and scaffold 138.

Internal layer 150 may be positioned and secured using scaffold 138.Securing layer 150 to layer 152 and scaffold 138 using water solubleadhesive would simplify removal of layer 150 and may also serve toidentify a saturated layer as it separates from the structural layer andthe scaffold. If layer 150 needed to be changed, any dressing or lidapplied over frame 140 may be disengaged. Layer 150 may be removed and areplacement layer may be inserted using scaffold 138 as a guide andengagement mechanism.

Referring now to FIG. 19, an alternate scaffold 139 may include lip 141to frictionally engage layer 150 without the use of adhesive or otherbonding agent. Scaffold 138 and or scaffold 139 may also include holesor other suitable openings such as holes 135 and 143 and openings 145 inshelf 133 and or lip 141 as illustrated in the associated close-upbottom views. Lip 141 may also permit usage and of any suitableabsorbent material in a non-contact position relative to the wound. Theabsorbent material may be frictionally engaged by lip 141 and supportedby scaffold 139.

Some materials may have directional characteristics, and when combinedin multiple layers may offer unique benefits. Many additionalcharacteristics may also be useful, for example, layer 156 of FIG. 20may be absorbent to absorb and retain exudate from the wound, and layer154 may be formed of a material providing dimensional stability orstructural integrity.

Similarly, referring to FIG. 22, layer 164 may be absorbent and layer166 may provide structural integrity and layer 166 may enclose layer 164to prevent exudates from wound side 144 transiting frame 140 and exitingthrough exterior side 146. Any suitable material may be selected foreach layer. Layer 168 may be any suitable material.

Referring now to FIG. 21, layers 158, 160 and 162 may also provide oneor more diagnostic indicators such as for example, ph level,temperature, moisture level, O² levels or any other suitable parameter.The state of the parameter may be indicated by one or more color statesof one or more layers.

Referring now to FIG. 23, frame 170 may include one or more internallayers such as layers 172, 174 and 176 and one or more absorbentappendages such as arm 178. Arm 178 and layer 176 may be composed of anysuitable material for absorbing exudates from wound 180. The physicalgeometry of arm 178 may vary for varying applications. For example, arm184 shown in FIG. 24 provides vertical relief from wound 180.

Alternatively as illustrated in FIG. 25, flexible absorbent appendagesmay also be secured to a frame such as frame 192. Absorbent appendages194 may be provided to absorb exudate from wound 180. Any suitablematerial or combination of materials may be used as appendages 194 suchas for example natural fibers such as cotton or any suitable man-madefiber such as polyurethane foam. Any other suitable configuration mayalso be employed such as enclosing one or more cotton balls or gauzewithin the space enclosed by a frame and a covering dressing.

Referring now to FIG. 26, frame 200 may also be used with a cover or lid202 to provide a controlled environment in enclosed space 204 adjacent awound site. Lid 202 may be removably engaged to frame 200 using anysuitable technique such as frictional or adhesive engagement. Lid 202may be formed of any suitable material or combination of materials suchas a structural grid layer with one or more laminate layers to obtainsuitable performance and moisture transmission/retention.

Alternatively, lid 202 may also include one or more absorptive elementssuch as cone 206 for removing moisture or exudate from wounds such aswound 210. Absorptive elements may have any suitable shape or dimensionand may be formed of any suitable material. For example, cone 206 may beformed of material that is selectively absorbent to remove exudate andunwanted fluids.

Enclosed space 204 may be further controlled as illustrated in FIG. 27.Frame 212 may include one or more access ports such as inlet port 214and outlet port 216. Use of access ports permits irrigation, treatment,and or debridement of wound 210 without removing wound protection shield218. Fluid or other material may be introduced into enclosed space 204through inlet port 214. In the case of used fluid or exudate, removalmay be accomplished using outlet port 216. Access ports such as inletport 214 and outlet port 216 may be reclosable to secure enclosed space204. Alternatively, frame 212 may be formed of material that permits asyringe to be inserted through the frame for insertion of material or toremove material. Access ports may also be formed in the cover or lid202.

Referring now to FIG. 28 enclosed vacuum space 211 may be created andmaintained by the use of a suitable cover or lid such as vacuum lid 205.A partial or complete vacuum may be created in space 211 by vacuumdevice 209 through adapter 207 or through a frame such as frame 212using inlet port 214 or outlet port 216. Using a frame and specificallyadapted lid such as lid 205 may permit a vacuum device such as vacuumdevice 209 to be located on lid 205 without creating unsatisfactorypressure on or adjacent wound 210. Lid 205 may require an adapter suchas adapter 207 or lid 205 may be specifically formed to adapt to avacuum device or connector to a vacuum device to create a full orpartial vacuum within space 211.

FIG. 29 illustrates the wound isolation and warming device 220,including tube 221, inner absorbent ring or strip 222 and breathablevapor barrier 223. The tube and absorbent strip are provided with anysuitable adhesive on the cutaneous surfaces of the tubing, the strip, orboth, to secure the device to the skin of a patient. The tubing is madeof polyethylene or other thermally conductive material, and may eitherbe bent and formed as necessary to adapt to the contours of a patient'sbody. The device also includes water supply and return conduits 224, anda warm water source 225 comprising a water reservoir, heater 226 (or anyother suitable heating means), pump 227, and appropriate thermostats,heating regulators and flow regulators. Pulsatile flow can be providedwith roller pump or centrifugal pulsatile flow pump. The heater andthermostat are preferably operable to maintain water temperature at atherapeutic temperature of about 105° F. (about 36-39° C.), but may beoperated to maintain higher or lower temperatures as medicallyindicated. The device is illustrated in place surrounding wound 100 onthe skin of a patient.

The device may be modified as shown in FIG. 30, in which the tube 221 inthe vicinity of the wound is perforated, such that apertures 228distributed along the inner wall of tubing 221 and any interveningportion of frame 222 direct water into the interior space 229 (definedby the frame) and onto the wound. Water is collected through return tube230 through suction ports 231 and appropriate suction pump 232 andcollected in wastewater tank 233. Water may be collected through adiscrete segment of the tube formed integrally with an interior wall orplug 234 provided to isolate the supply and suction tubes.Alternatively, the suction tube may be butt-joined with the supply tube.Used fluid may also be collected with a second, discrete suction tube,or through an additional lumen and ports in the first tube.

Tube 221 may be made or formed in any cross section shape including butnot limited to cylindrical, rectangular, trapazoidal or any othersuitable shape. A suitable shape of tube 221 may be selected to controlthe flow of thermal energy around the wound, generally to increase thetemperature of the wound site, however cooling may also be provided.Tube 221 may also include one or more insulating layers to control thethermal energy and prevent unwanted losses. Adhesive may also be used asnecessary on tube or its adjacent surfaces to secure tube 221 in use.

In use, the devices of FIGS. 29 and 30 are applied to a patient so thatthe tubing substantially circumscribes a wound, and fixed to the skin ofthe patient with adhesives on the cutaneous surfaces of the tubing andabsorbent ring (or secured with bandages, wherever adhesives areinadequate or inappropriate). The pump and heater are operated tomaintain warm fluid flow through the tube, to maintain a warmenvironment proximate the wound. In the closed system of FIG. 29, thefluid is returned to reservoir, reheated and re-circulated through thesystem. When using the device of FIG. 30, the suction pump is operatedto draw fluid from the wound environment and deliver that fluid to thewastewater tank. Therapeutic agents such as antibiotics may be added tothe warm water source when medically indicated.

Referring to FIG. 31, absorbent layer 164 may be oriented to be out ofcontact with the patients skin. Absorbent layer 164 may be configured toabsorb and or store exudate from a wound. Relief such as relief 240isolates the absorbed exudate away from the patients skin. Relief 240may be selected to be any suitable dimension.

Dynamic exudate management and removal may be provided by layer 242 ofFIG. 32. The material of layer 242 is selected to flex when new and toextend over relief 244 and contact the surface of a wound to engageexudate. Upon absorbing exudate, layer 242 will contract to draw exudateacross relief 244 to continue wicking exudate from the wound withabsorbent layer 242 out of contact with the wound or the patients skin.

Referring to FIG. 33, exudate 246 may be conducted from wound 210 andenclosed space 258 with alternate frame 248. The material of layer 250may be selected to perform as a conduit by drawing exudate 246 fromwound 210 and transferring exudate 246 to one or more storage layers ofdressing 252 such as layer 254. Layer 250 will not retain exudate 246.Absorbent layer 254 may be any suitable material and may also beexpandable. Area 256 of dressing 252 may permit viewing of wound 210 andmay have a selected permeability to enhance control of enclosed space258.

Wound 260 of FIG. 34 may produce exudate 263. An alternate frame 262 mayconduct exudate away from wound 260. Membrane 264 may surround frame 262or may otherwise be included as a layer of frame 262. Membrane 264 mayallow exudate to pass in only one direction, away from the wound. Onceexudate 263 has passed membrane 264 it may be absorbed or otherwiseconducted along drain 261 away from the wound. Drain 261 may include anaccess port 266 which may accommodate continuous or intermittentconnection for withdrawal or drainage of exudate from drain 261 intoreservoir 265. Reservoir 265 may be adjacent to wound 260 or may beremotely located by interconnecting reservoir 265 to drain 261 with atube or other suitable element. Alternatively, reservoir 265 may be usedto introduce water or other suitable solvent or cleanser into drain 261to expedite removal of exudate 263.

Referring now to FIG. 35, use of access ports permits exudate managementwith irrigation, treatment, and or debridement of a wound such as wound270 without removing wound protection shield 272. Fluid and or othermaterial may be introduced, and exudate, fluid and or other material maybe removed from enclosed space 276 through port 274. Access ports suchas port 274 may adopt any suitable geometry for engaging various tubes,such as tube 271, syringes, and devices such as reservoir 273. Ports maybe reclosable using any suitable technique to secure enclosed space 276.

Adapters such as adapter 275 may engage port 274 to permit leak proofaccess to enclosed space 276. As adapter 275 enters port 274 the port isopened, and as adapter 275 is withdrawn port 274 closes and withdrawalof an adapter cleanses port 274.

Referring now to FIG. 36, conformable frame 310 may have a step varyingheight 312 from inner step 311 which has the lowest height 312 andsubsequent steps such as steps 313 and 315 have increasing heights. Theheight variations may be distinct such as steps, or it may be gradualand continuous as shown in conformable frame 320 of FIG. 37. The heightvariations distribute pressure that might otherwise impact the wound, tosurrounding tissue removed from the wound. As pressure increasescompressing outer wraps of conformable frame 310, the inner wraps beginto provide support increasing pressure resistance. Conformable frame 310may be formed of one or more layers 314 and or 316 as discussed above,and may also include a conduit layer 250 adjacent to wound 300 andforming the perimeter of wound space 309.

Conformable frame 320 of FIG. 37 illustrates a continuously increasingheight from inner edge 322 to outer edge 324. Characteristics ofconformable frame 320 may change gradually and continuously from firstend 322 to second end 324 or there may be one or more zones such aszones 328 a and 328 b. Each zone may have different compressionresistance, absorbance or any other suitable characteristics.

Thus, while the preferred embodiments of the devices and methods havebeen described in reference to the environment in which they weredeveloped, they are merely illustrative of the principles of theinventions. Other embodiments and configurations may be devised withoutdeparting from the spirit of the inventions and the scope of theappended claims.

1-11. (canceled)
 12. A shield for protecting a wound, the shieldcomprising: a conformable frame having a preformed shape to circumscribethe wound, the preformed shape comprising a preformed cross-section, apreformed span, and a preformed geometry; a first adhesive layersecuring the conformable frame around the wound; a lid engaging theconformable frame to enclose a space about the wound, the lid configuredto allow for moisture transmission; and a second adhesive layer securingthe lid to the conformable frame; wherein the lid and the conformableframe are configured to retain a partial vacuum within the space whensuction is applied thereto.
 13. The shield of claim 12, wherein theconformable frame comprises: an absorbent layer for absorbing woundexudate.
 14. The shield of claim 13, wherein a portion of the absorbentlayer extends into the wound.
 15. The shield of claim 13, wherein theconformable frame further comprises: an additional layer, an interfacebetween the absorbent layer and the additional layer being orientedperpendicular to a surface of the wound.
 16. The shield of claim 13,wherein the conformable frame further comprises: an additional layer, aninterface between the absorbent layer and the additional layer beingoriented parallel to a surface of the wound.
 17. The shield of claim 12,further comprising: one or more absorbent extremities extending into thespace.
 18. The shield of claim 17, wherein the one or more absorbentextremities comprise polyurethane foam.
 19. The shield of claim 17,wherein the one or more absorbent extremities are formed integral to theconformable frame.
 20. The shield of claim 12, wherein the lid comprisesan exudate absorbing material, the conformable frame configured totransport exudate from the wound to the lid.
 21. The shield of claim 12,further comprising one or more access ports through the conformableframe, wherein the partial vacuum is created using a vacuum device thatis connected to the one or more access ports.
 22. A method of shieldinga wound on a patient, the method comprising: selecting a preformedconformable frame to circumscribe a wound, the conformable frame havinga preformed cross-section, a preformed span, and a preformed geometry;adhering the preformed conformable frame around the wound; afteradhering the preformed conformable frame around the wound, securing amoisture permeable dressing to the conformable frame so as to enclose aspace about the wound; and applying suction to create at least a partialvacuum within the space.
 23. The method of claim 22, wherein themoisture permeable dressing comprises an exudate absorbing material, theconformable frame configured to transport exudate from the wound to thedressing.
 24. The method of claim 23, further comprising extending theexudate absorbing material into the wound.
 25. The method of claim 23,wherein the conformable frame further comprises: an additional layer, aninterface between the absorbent layer and the additional layer beingoriented perpendicular to a surface of the wound.
 26. The method ofclaim 23, wherein the conformable frame further comprises: an additionallayer, an interface between the absorbent layer and the additional layerbeing oriented parallel to a surface of the wound.
 27. The method ofclaim 22, further comprising: extending one or more absorbentextremities into the space.
 28. The method of claim 27, wherein the oneor more absorbent extremities comprise polyurethane foam.
 29. The methodof claim 27, wherein the one or more absorbent extremities are formedintegral to the conformable frame.
 30. The method of claim 22, whereinthe lid comprises an exudate absorbing material, the method furthercomprising transporting exudate from the wound to the lid using theconformable frame.
 31. The method of claim 22, wherein applying suctioncomprises applying suction to create at least a partial vacuum withinthe space using a vacuum device connected to one or more access ports.